Integrated Vascular Delivery System

ABSTRACT

An integrated vascular delivery system having a frame configured to receive a catheter insertable in a patient to deliver fluid at an insertion site. The frame includes a first hub, a second hub, and a pair of flexible lateral members extending between the hubs and including a tubular lateral member. The system also includes a fluidic channel that fluidically communicates with the catheter, wherein the fluidic channel passes through the tubular lateral member and at least one of the hubs, and includes a fixed turnabout portion in which fluid flows in a direction different from that within the catheter. The first and second hubs provide anchoring points on the patient distributed around the insertion site and on opposite ends of the catheter, thereby anchoring the frame to the patient and stabilizing the catheter. A method is provided for using an integrated vascular delivery system.

REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/427,714 filed on Feb. 8, 2017, which is a continuation of U.S. patentapplication Ser. No. 14/602,735 filed on Jan. 22, 2015 (now U.S. Pat.No. 9,592,366, issued on Mar. 14, 2017), which is a continuation of U.S.patent application Ser. No. 13/930,797 filed on Jun. 28, 2013 (now U.S.Pat. No. 8,968,252, issued on Mar. 3, 2015), which is a continuation ofU.S. patent application Ser. No. 13/665,162 filed on Oct. 31, 2012 (nowU.S. Pat. No. 8,668,674, issued on Mar. 11, 2014), which is acontinuation of U.S. patent application Ser. No. 12/855,013, filed onAug. 12, 2010 (now U.S. Pat. No. 8,323,249, issued on Dec. 4, 2012),which claims the benefit of U.S. Provisional Application No. 61/233,859,filed on Aug. 14, 2009. The entire disclosure of each of the aboveapplications is incorporated herein by reference.

FIELD

The present disclosure relates generally to the medical care field, andmore specifically to an improved vascular delivery system in theintravenous therapy field.

BACKGROUND

This section provides background information related to the presentdisclosure which is not necessarily prior art.

Patients undergoing medical treatment often require a form ofintravenous (IV) therapy, in which a fluid is administered to thepatient through a vein of the patient. IV therapy is among the fastestways to deliver fluids and medications into the body of the patient.Intravenously infused fluids, which typically include saline, drugs,blood, and antibiotics, are conventionally introduced to the patientthrough a flexible catheter positioned at any of several venous routes,such as peripheral veins and central veins.

To set up IV therapy with conventional devices and methods, thecaregiver positions the catheter over the selected vein and uses aneedle within the catheter to pierce the skin and allow insertion of thecatheter into the vein. The catheter is typically positioned such thatthe distal inserted end of the catheter points toward the midline of thepatient (e.g., for a peripheral IV line on the arm, the catheter body ispositioned on the forearm and points toward the elbow). The caregiverthen withdraws the needle from the catheter, leaving the catheterinserted in the vein. The proximal end of the catheter, relative to themidline of the catheter, is fixed to the end of a catheter hub that isproximal relative to the midline of the patient. The caregiver connectsthe catheter to a fluid supply through external tubing, includingextension tubing that is typically attached to the distal end of thecatheter hub relative to the midline of the patient, and that thecaregiver typically bends into a U-shape. To avoid unscheduled IV linerestarts, the catheter and tubing are typically secured against the skinof the patient with tape or similar catheter stabilization devices(CSDs) such as adhesive stabilizing pads that restrain the catheterbody.

However, conventional devices and methods for IV therapy have drawbacks.The extension tubing may catch on nearby obstacles during patientmovement or caregiver manipulation, which may cause painful veinirritation and compromise the IV. Tape and other existing CSDs are notoptimal for stabilization because securing the round, rigid, and bulkycomponents such as the catheter and tubing against the skin can bedifficult and ineffective. Tape and other existing CSDs do not fullyprevent the catheter from moving within the vein, which leads topatient-endangering complications including catheter dislodgement,infiltration (fluid entering surrounding tissue instead of the vein),and phlebitis (inflammation of the vein). Adhesive stabilizing pads tendto result in other undesired effects, such as skin irritation and/orbreakdown due to prolonged concentrated adhesion to the skin.Furthermore, tape and current CSDs restrain the catheter on only oneside of the catheter insertion site, and do not prevent the catheterfrom painfully and dangerously pivoting around the insertion site andmoving within the vein.

Thus, there is a need in the intravenous therapy field to create animproved vascular delivery system that overcomes one or more of thedrawbacks of the conventional vascular delivery systems. This inventionprovides such an improved vascular delivery system.

DRAWINGS

The drawings described herein are for illustrative purposes only ofselected embodiments and not all possible implementations, and are notintended to limit the scope of the present disclosure.

FIG. 1 is the integrated vascular delivery system of a preferredembodiment;

FIG. 2 is a semi-transparent overhead view of the integrated vasculardelivery system of a preferred embodiment;

FIG. 3 is a semi-transparent view of the integrated vascular deliverysystem of another preferred embodiment;

FIGS. 4A-4D are semi-transparent overhead views of variations of theintegrated vascular delivery system of another preferred embodiment;

FIGS. 5A-5F are schematics of a method for using the integrated vasculardelivery system of a preferred embodiment; and

FIGS. 6A-6C are overhead, side, and perspective views, respectively, ofa variation of the step of folding in a method for using the integratedvascular delivery system of a preferred embodiment.

Corresponding reference numerals indicate corresponding parts throughoutthe several views of the drawings.

DETAILED DESCRIPTION

The following description of preferred embodiments of the presentteachings is not intended to limit the disclosure to these preferredembodiments, but rather to enable any person skilled in the art to makeand use this invention.

1. Integrated Vascular Delivery System

As shown in FIGS. 1 and 2, the integrated vascular delivery system 100of the preferred embodiments includes: a frame 110 configured to receivea catheter 170 insertable in a patient to deliver fluid at an insertionsite, in which the frame includes a first hub 120, a second hub 130, anda pair of flexible lateral members 140 extending between the hubs andincluding a tubular lateral member 140′; and a fluidic channel 150 thatfluidically communicates with the catheter, wherein the fluidic channel150 passes through the tubular lateral member 140′ and at least one ofthe hubs, and includes a fixed turnabout portion 156 in which fluidflows in a direction different from that within the catheter 170. Thefirst and second hubs preferably provide first and second anchoringpoints 122 and 132, respectively, on the patient such that the anchoringpoints are distributed around the insertion site 112 and on oppositeends of the catheter, thereby anchoring the frame to the patient andstabilizing the catheter 170. Fluid flow in the turnabout portion 156 ofthe fluidic channel 150 is preferably opposite of that within thecatheter, and the turnabout portion is preferably fixed in such a way asto reduce the likelihood of snagging or catching on nearby objects. Inone preferred embodiment, the system includes a second tubular lateralmember 140′ and a second fluidic channel 150 that fluidicallycommunicates with the catheter 170 and passes through the second tubularlateral member 140′. In a preferred embodiment, the frame 110 isconfigured to receive the catheter as an integral part of the system, inwhich the catheter 170 is embedded in a portion of the frame, and morepreferably in one of the hubs. However, in an alternative embodiment theframe 110 is configured to receive a separate catheter, which may snapfit into the frame.

In some versions of the system, the system further includes at least oneextension tube 180 and/or a fluid supply adapter 182 that delivers fluidfrom a fluid supply to the fluidic channel. The system functions toenable access to the vein of a patient undergoing intravenous (IV)therapy with an included catheter, administer fluids intravenouslythrough the catheter, and securely and safely stabilize the catheter onthe patient. The system is preferably used to administer drugs,antibiotics, saline, or blood, but may be used to administer anysuitable fluid to a patient. The system is preferably used to create,stabilize, and maintain an IV line on a peripheral vein such as on thearm, hand, or leg, but may alternatively be used for central orperipheral venous access on the neck, chest, or abdomen, or any suitableintravenous intra-arterial location. The system may further be used tocreate, stabilize, and maintain any suitable catheter- based access to apatient, such as for the transfer of cerebrospinal fluid.

In a preferred embodiment, the catheter 170, frame 110, fluidic channel150, extension tubing 180, and/or fluid supply adapter 182 arepre-assembled during manufacture of the system to provide an integratedsystem that is cost-efficient, reduces IV setup time, and packagingwaste. The system preferably stabilizes the catheter 170 on the patientwith anchoring points distributed around the insertion site 112, morepreferably on at least two opposing sides of the insertion site 112,which may reduce or eliminate painful and dangerous pivoting motions ofthe catheter 170 that may occur during normal patient movement and/orcaregiver manipulations. The system is preferably streamlined byaligning the catheter with the fluid supply adapter and reducingexternal free tubing, which reduces the likelihood of the systemcatching or snagging on nearby obstacles. The system is preferably aclosed system that reduces possible points of contamination and fluidleakage, which improves safety for both the patient and the caregiver.The system is preferably compatible with existing conventional catheterinsertion and IV setup procedures, which enables a caregiver to easilyuse the system without significant additional training.

The frame 110 of the integrated vascular delivery system functions tostabilize the system on the patient. As shown in FIGS. 1 and 2, theframe 110 preferably includes a first hub 120 on one end of the framethat provides a first anchoring point 122 on the patient, a second hub130 on an end of the frame approximately opposite to the first hub thatprovides a second anchoring point 132 on the patient, and two flexiblelateral members 140 that extend between and flexibly connect the firsthub and the second hub, such that the first hub and the second hub moverelative to one another with a significant number of degrees of freedom.In particular, the lateral members 140 preferably are reversiblybendable to fold one of the first and second hubs over the other hub. Asshown in FIG. 2, in a preferred embodiment, the lateral members aresubstantially parallel such that the frame 110 forms an approximatelyrectangular perimeter 114 around the catheter 170 and insertion site112. In variations of the frame 110, the frame may include any suitablenumber of hubs and any suitable number of lateral members, such that theframe forms a perimeter 114 of any suitable shape and size around theinsertion site 112. The frame 110 preferably allows visualization of theinsertion site 112 of the catheter, such as by leaving an open uncoveredarea around the catheter, although alternatively the system may includea cover that is transparent, translucent, opaque, or any suitable kindof material, that extends over the frame to cover the insertion site 112and/or catheter 170. As shown in FIG. 5E, the frame is preferablysecured to the patient by securing the first hub 120 and second hub 130to the patient at the first and second anchoring points, respectively,on opposite sides of the insertion site 112 (preferably distal andproximal to the insertion site) and opposite ends of the catheter 170,thereby stabilizing the catheter. However, the frame 110 mayadditionally and/or alternatively be secured by securing only the firsthub, only the second hub, the lateral members and/or or any othersuitable portion of the frame. The frame may alternatively stabilize thecatheter at anchoring points located at any suitable locations relativeto the catheter insertion site 112. The frame 110, when secured to thepatient, enables the integrated vascular system to stabilize thecatheter more effectively than conventional catheter securement devicesthat stabilize the catheter on only one side of the insertion site 112,because stabilizing the catheter on two opposite sides of the insertionsite reduces pivoting motions of the catheter that may occur duringnormal patient movement and/or caregiver manipulations.

The first hub 120 of the frame 110 functions to provide a firstanchoring point 122 for the frame. As shown in FIG. 2, in a preferredembodiment, the first hub 120 further functions to house a portion ofthe fluidic channel 150 within the first hub. The first hub 120 ispreferably located on the proximal end of the frame relative to themidline of the patient, such that the first hub provides a firstanchoring point 122 proximal to the catheter insertion site relative tothe midline of the patient. Alternatively, the first hub 120 may belocated on any suitable part of the frame relative to the insertion site112 to provide a first anchoring point 122 at any suitable locationrelative to the insertion site 112. As shown in FIG. 5E, the first hub120 is preferably secured to the skin of the patient with tape, but mayadditionally and/or alternatively be secured with an adhesive located onthe underside of the first hub 120; elastic straps; straps fastened withfasteners such as hooks, hook and loop, or magnets; or any suitablesecurement mechanism. The first hub may alternatively not be secured tothe skin of the patient. In one specific embodiment, the first hubpreferably has a relatively wide and thin profile, with a width ofapproximately 20-30 mm and a thickness of approximately 5 mm. However,the first hub may alternatively be any suitable shape and size. A largewidth is advantageous for distributing forces over a greater area on theskin, which decreases the chances of the patient developing skinirritations, sores, and other degradations. The thin profile, which isapproximately half as thick as conventional vascular access devices,decreases the risk of the hub catching or snagging on bed equipment orother nearby obstacles that could cause the catheter to move within thevein and cause complications such as catheter dislodgement,infiltration, and phlebitis. As shown in FIG. 1, the first hub 120preferably has rounded edges and preferably has an upper surface that isslightly arched along its lateral axis. The arched upper surface mayadapt the first hub to receive tape along the arch for securement to thepatient. The first hub may additionally have features that conform tothe body of the patient, such as an underside concavity to conform to alimb, finger, or knuckle.

The first hub 120 is preferably made of a rigid or semi-rigid material,such as nylon or silicone, to provide structural support to the frame110 for stabilizing the system. However, the first hub may alternativelybe made of any polymer, metal, composite, or other suitable material.The first hub may be transparent or semi- transparent to allowvisualization of the fluid channel 150. The first hub is preferablymanufactured through injection molding, but may alternatively bemanufactured through stereolithography, casting, milling, or any othersuitable manufacturing process known to one skilled in the art.

The first hub 120 and/or the second hub 130 may include a sensor 116that measures a biometric parameter such as temperature, blood pressure,or pulse rate of the patient. The sensor 116 may additionally and/oralternatively sense any suitable parameter such one pertaining to thefluid, such as pH or flow rate.

The portion of the fluidic channel 150 fixed to the first hub 120 may becoupled to an extension tube and/or fluid supply adapter that functionto deliver fluid from a fluid supply to the fluidic channel 150 of thesystem. The fluid supply adapter preferably includes a connector thatattaches the extension tube to a fluid supply, which is preferably apole-mounted IV bag that supplies fluid through tubing, but mayalternatively be a syringe, pump, or other suitable fluid supply. Asshown in FIG. 4, the connector is preferably a standard female luer lockconnector or Y-connector that commonly interfaces with conventional IVbags, as known to one skilled in the art. Alternatively, the connectormay be any suitable male or female connector that is adapted tointerface with a fluid supply. The extension tube further functions toprovide stress relief if the system is jostled and is preferably made offlexible tubing, such as polymer tubing, but may be a passageway made ofany other suitable material. Flexible tubing is advantageous forrelieving mechanical stress and reducing chances of patient injury ifthe system is suddenly disturbed, such as during patient movement orcaregiver manipulations. The extension tube is preferably long enough toprovide stress relief if needed, but short enough to reduce the chancesof the extension tube catching or snagging on nearby obstacles. Thelength of the extension tube may alternatively be any suitable length,and may depend on the specific application of the system. Otherdimensions of the fluid passageway, such as outer diameter and innerdiameter, may depend on the specific application of the system.

In alternative versions of the system, the system may include more thanone extension tube and/or connector, to facilitate delivering fluid frommultiple fluid supplies simultaneously to the system. For example, in anembodiment of the system that includes two fluidic channels 150, thesystem may include a first extension tube that delivers a first fluid toa first fluidic fluidic channel, and a second extension tube thatdelivers a second fluid to the second fluidic channel. However, twoextension tubes may be useful in applications involving theadministering of two separate fluids through the same fluidic channeland catheter.

The second hub 130 of the system is preferably similar to the first hub120, except as noted below. The second hub 130 functions to provide asecond anchoring point 132 for the frame 110, preferably on a distal endof the frame relative to the midline of the patient. The second hub ispreferably secured distal to the catheter insertion site 112 relative tothe midline of the patient, and in one specific embodiment,approximately 15 mm or less distal to the insertion site. However, thesecond hub may alternatively be secured in any suitable locationrelative to the insertion site 112. As shown in FIG. 2, the second hub130 preferably includes a self-sealing septum 134. The self-sealingseptum of the second hub functions to provide an opening for aninsertion needle to be inserted into the catheter 170 prior to catheterinsertion, and to seal the internal channel second hub after withdrawalof the insertion needle within the catheter after catheter insertion, toprevent escape or leakage of blood and other potential biohazards orother fluids. As shown in FIG. 2, the septum 134 is preferably locatedon the distal side of the second hub 130 relative to the midline of thepatient, and is approximately concentric with the catheter 170. Theseptum is preferably made of a flexible material that self-seals to forma hermetic seal. This self-sealing septum prevents fluid from passingthrough the distal side of the second hub relative to the midline of thepatient, contributing to a closed system in which blood and other fluidswill not exit the integrated vascular delivery device after the needlepunctures the patient. The septum 134 may alternatively be sealed with aplug, such as a stopper or sealant material applied to the septum.

The second hub 130 may additionally include a reservoir between theseptum 134 and the catheter 170. This reservoir may serve as a flashchamber to contain any blood leakage during withdrawal of the insertionneedle from the catheter after catheter insertion, or may serve anyother suitable purpose.

The second hub 130 may additionally include features at the connectionbetween the second hub 130 and the lateral members that reduce creasing,collapsing, fracture, or other damage in the lateral members when thelateral members are folded to pass one of the hubs over the other hubduring insertion of the catheter into the patient. As an example, thesecond hub may include rounded edges that are contoured to the naturalbend radius of the lateral members, to prevent the lateral members frombending too sharply or bending against a sharp edge. As another example,the second hub may include relief cutouts and/or other reinforcementsthat encourage the lateral members to bend to their natural bend radius.

The lateral members 140 of the frame 110 function to provide structuralstability to the frame by stabilizing the first hub 120 relative to thesecond hub 130. As shown in FIGS. 1 and 2, the frame 110 preferablyincludes two flexible lateral members, including at least one tubularlateral member 140′. However, in alternative versions of the frame, theframe may include fewer or more lateral members. The lateral memberspreferably provide structural stability to the frame, and the tubularlateral member 140′ or members preferably house a portion of the fluidicchannel 150. The lateral members are preferably parallel with oneanother and preferably extend between the first and second hubs, to forma perimeter 114 around the catheter 170. However, the lateral membersmay be in any crossed, non-parallel or any suitable orientation. Thelateral members preferably allow the first hub and the second hub tomove relative to one another with a significant number of degrees offreedom, including displacement in the compression direction (andsubsequent displacement in the tension direction) along the axis of thecatheter, displacement in both directions along the other two axes,twisting in both directions along the axis of the catheter, and bendingin both directions along the other two axes. In particular, the lateralmembers are preferably reversibly bendable to fold one of the first andsecond hubs over the other hub. As shown in FIGS. 58 and 6, duringinsertion of the catheter into the patient, the lateral members arepreferably folded to fold the first hub 120 over the second hub 130,which opens the perimeter 114 around the catheter and exposes thepenetrating distal tip of the catheter. The length of the lateralmembers is preferably approximately 30%-50% longer than the catheter,but may alternatively be shorter or longer depending on the specificapplication. At least one lateral member 140 may include markings, suchas markings similar to those on a ruler, to indicate the depth to whichthe catheter is inserted into the patient. The lateral members arepreferably made of an extruded flexible polymer cut to length and moldedto one or both hubs, but may alternatively be made through any suitablemanufacturing process and/or out of any suitable material.

In a first preferred embodiment, the pair of lateral members includes atubular lateral member 140′ and a solid lateral member 140″. The tubularlateral member is preferably a generally straight, soft, and flexiblehollow channel such as medical tubing, but may alternatively be anysuitable structure with an internal fluid passageway that houses aportion of the fluidic channel 150. The tubular lateral member ispreferably rigid enough to provide structural support to the frame 110,but flexible enough to bend and fold across its length without damageduring insertion of the catheter. The tubular lateral member may includeadditional features that enhance the ability to bend without damage. Asan example, the tubular lateral member may be tapered along its lengthand include a thicker wall and/or larger outer diameter near the bendingstress point at the second hub 130. As another example, the tubularlateral member may have an elliptical cross-section that is moreresistant to bending damage. As another example, at least a portion ofthe first lateral member may include extendable and foldable pleats,similar to an accordion, that allow curvature of the lateral member withless bending stress.

As shown in FIG. 2, in the first preferred embodiment, the solid lateralmember is preferably similar in shape and size to the first lateralmember so that the frame 110 is structurally symmetrical, but preferablyis a “dummy” structure in that it does not house a portion of thefluidic channel 150. The solid lateral member 140″ preferably isapproximately identical in flexibility and strength as the tubularlateral member 140′. However, the solid lateral member 140″ mayalternatively have a different shape (e.g., larger diameter or largerthickness) to further enhance stabilization of the first hub 120relative to the second hub. Similar to the tubular lateral member 140′,the solid lateral member 140″ may additionally include features thatenhance the ability to bend without damage.

As shown in FIG. 3, in a second preferred embodiment, the pair oflateral members includes two tubular lateral members 140′, similar tothe tubular lateral member of the first preferred embodiment. In thisembodiment, the tubular lateral members 140′ are preferably identicaland house two separate fluidic channels that direct a first and a secondfluid flow between the hubs. However, the tubular lateral members mayalternatively be different for serving different purposes. For example,two tubular lateral members 140′ may house two separate fluidic channelsthat are adapted to carry different types of fluids (e.g., differentdensities), and the tubular lateral members may have different wallthicknesses to compensate for the different fluids and achievestructural symmetry in the frame. As another example, the tubularlateral members may have different sized lumens.

In some alternative versions, the frame 110 may include fewer or morethan two lateral members, in any suitable combination and permutation oftubular and solid lateral members. All of the lateral members may besolid, tubular, or hollow, or any combination thereof In somealternative versions, the lateral members may merge and/or branchupstream and/or downstream. For example, in one alternative embodimentthe lateral members may include portions of a thin, flexible sheet thatare merged proximal and distal to the insertion site, such that thecatheter tip passes through a slot-like opening between the mergedportions.

The fluidic channel 150 of the system functions to deliver fluid from afluid supply to the catheter, and in some embodiments, deliver fluid toand from the catheter. The fluidic channel 150 may additionally and/oralternatively deliver fluid from the catheter 170, such as transferringfluid removed from the patient through the catheter to an externalreservoir. As shown in FIG. 2, the fluidic channel 150 preferablyincludes at least one portion that is fixed within at least one of thehubs and/or within a tubular lateral member 140′. More preferably, thefluidic channel 150 includes a first portion 152 fixed within the firsthub 120, a second portion 154 passing through a tubular lateral member140′, and a turnabout portion 156 fixed within the second hub 130. In afirst variation, the fluidic channel 150 may be a continuous length suchas a single piece of tubing fixed in the first hub, passing through orserving as the tubular lateral member 140′, fixed in the second hub 130and fluidically coupled to the catheter. In a second variation, thefluidic channel 150 includes separate lengths such as separate tubingsegments joined at various points such as through heat sealing, otherplastic welding methods, or fluidic couplings. In a third variation, thefluidic channel 150 includes tubular cavities within one or both hubs,to which a tubular segment joins through a process similar to the secondvariation. In the third variation, the tubular cavities in the firstand/or second hub may be formed by molding, drilling, laser cutting, orin any suitable manufacturing process. In a fourth variation, thefluidic channel 150 may be external to one or more of the hubs andlateral members, such that at least a portion of the fluidic channel ismounted to and passes over the exterior of a hub or lateral member.Other variations of the fluidic channel include every combination andpermutation of these variations.

As shown in FIG. 2, the first portion 152 of the fluidic channel 150preferably includes an inlet located at the midline of the proximal sideof the first hub and an outlet located on the distal side of the firsthub, relative to the midline of the patient. However, the inlet andoutlet of the internal channel may be located on any suitable positionon the first hub. The inlet of the first portion of the fluidic channel150 preferably receives fluid from the extension tubing 180, and theoutlet of the internal channel preferably delivers the fluid to at leastone of the lateral members of the frame 110, but fluid may alternativelyflow in reverse order. The first portion of the fluidic channel 150preferably includes right angles to direct fluid from the midline of thefirst hub to a tubular lateral member 140′ located on the side of theframe. However, the first portion of the fluidic channel mayalternatively be curved (shown in FIGS. 3 and 4), curvilinear, or anysuitable shape for fluid flow through the first hub 120 to the lateralmember. The first portion of the fluidic channel may be connected to theextension tube by inserting the extension tube into a hollow recessaligned with the fluidic channel in the first hub and sealing the recessedge with epoxy, but the first hub may alternatively be coupled to theextension tube by press fitting the extension tube into the recess inthe first hub, sealing a butt joint with epoxy, or any suitable couplingprocess.

As shown in FIG. 2, the second portion 154 of the fluidic channel 150preferably passes through a tubular lateral segment, between the firstportion in the first hub 120 and the turnabout portion in the second hub130.

As shown in FIG. 2, the turnabout portion 156 of the fluidic channel 150is preferably fixed in such a way to direct fluid flow in a directiondifferent from fluid flow within the catheter 170. The turnabout portionpreferably directs fluid flow to a direction opposite of that within thecatheter, or in an approximately 180-degree turn. The turnabout portion156 may include right angles, an elliptical, or a circular turn. Theturnabout portion of the fluidic channel is preferably fixed or embeddedwithin the second hub 130 (distal relative to the midline of thepatient). Since the catheter is typically inserted in the patient suchthat its penetrating end points proximally towards the heart of thepatient, the approximate 180-degree turn of fluid flow within theinternal channel allows the extension tubing to lie proximal to theinsertion site 112 relative to the midline of the patient. This positionof the fluid supply channel advantageously allows a stand supporting theIV bag or other fluid supply to be kept near the head of a bed orotherwise proximal to the insertion site relative to the midline of thepatient, as is typically desired and practiced in patient treatmentsettings. The internalized fluid flow turn in the turnabout portion ofthe fluidic channel 150 also is advantageous because it reduces externalfeatures that can get caught or snagged on nearby obstacles and disturbthe IV setup. Another effect of the turnabout portion is that if theextension tube and/or additional tubing from a fluid supply is pulled orcaught, the turnabout portion may enables the frame to stabilize thecatheter more effectively by causing the catheter to be pulled furtherinto the patient. For example, in a common catheter placement where thecatheter is placed on the forearm with its distal tip pointingproximally towards the crook of the elbow of the patient, if theextension tubing is accidentally pulled posteriorly towards the patient,the tubing will in turn pull the turnabout portion of the fluidicchannel and the distal second hub 130 in a posterior direction, therebypulling the catheter tip proximally and further into the blood vessel ofthe patient.

In another preferred embodiment, as shown in FIGS. 3-4, the systemincludes a second fluidic channel 150 that is preferably similar to thefirst fluidic channel 150, but may alternatively be any of thevariations of the first fluidic channel. The second fluidic channelpreferably passes through a second tubular lateral member 140′. Thesecond fluidic channel preferably receives a second fluid, which may bethe same or different from the first fluid supplied to the first fluidicchannel. In this embodiment, as shown in FIGS. 4A-4C, the system mayfurther include a second extension tube 180 that supplies a second fluidto the second fluidic channel. However, as shown in FIG. 40, the systemmay include only one extension tube that supplies fluid to one or bothfluidic channels. The fluidic channels may have separate inlets on thefirst hub or may share the same inlet on the first hub in which flow maybe regulated with valves or other fluid control means. In one variation,the first and second fluidic channels preferably fluidically communicatewith the same catheter in the second hub 130, coupled to the catheter atthe same (FIG. 40) or different points (FIG. 4C) along the length of thecatheter. In this variation, the system preferably includes a flowcontrol system 160 that selectively restricts flow of one or both of thefluids to the catheter and therefore to the patient. The flow controlsystem may include one or more valves 162, such as at the extensiontubes (FIGS. 4A-4B), at the junction with the catheter 170 (FIGS.4C-40), or any suitable location. The flow control system 162 mayadditionally and/or alternatively use pressure drops, vents, or anysuitable technique for controlling fluid flow among the fluidic channelsand catheter. The flow control system 162 may also be present in anembodiment that includes only one fluidic channel. In another variation,the first and second fluidic channels preferably fluidically communicatewith a catheter with dual lumens, such that one catheter lumen iscoupled to the first fluidic channel and another catheter lumen iscoupled to a second fluidic channel. In yet another variation, the firstand second fluidic channels fluidically communicate with separatecatheters. Additional variations expand on these variations with threeor more fluidic channels.

Furthermore, the first hub 120 and/or second hub 130 may includemultiple internal channels that merge downstream, such that the numberof inlets is greater than the number of outlets in the hub. In somevariations, one of the hubs may include one or more internal channelsthat branch downstream, such that the number of inlets is less than thenumber of outlets. One of the hubs may include one or more internalchannels that both branch and merge within the first hub. Multipleinternal channels may deliver fluid to multiple catheters or multiplelumens of a catheter.

In some embodiments, the system further includes a catheter 170 having aproximal portion embedded in a portion of the frame, and more preferablyin the first or second hub 130. The catheter 170 of the integratedvascular system functions to administer fluids for IV therapy to thepatient. The catheter 170 is preferably a conduit insertable into ablood vessel of the patient, but may be any suitable type of catheter.As shown in FIGS. 1-4, the catheter is preferably fluidly connected tothe turnabout portion of the fluidic channel and located at the midlineof the proximal side of the second hub 130 relative to the midline ofthe patient. The catheter 170 is preferably aligned with the extensiontubing, which reduces and streamlines extraneous external tubing andother connections that may get caught or snagged on nearby obstacles,which is painful and dangerous for the patient. However, the cathetermay be positioned at any suitable location on the second hub. In someembodiments, the catheter may be positioned such as having its proximalend fluidically connected to the first, more proximal hub and pointingtowards and such that the system lacks a turnabout portion of thefluidic channel. For example, the catheter may be fluidic connected tothe first hub that is more proximal to the patient, The catheter ispreferably made of a soft, flexible polymer but may be made out of anysuitable material. Dimensions of the catheter, including length,diameter, and cannula size, will depend on the specific application.Catheters are known and used in the art, such as that described in U.S.Pat. No. 5,358,493 entitled “Vascular access catheter and methods formanufacture thereof”, which is incorporated in its entirety by thisreference. The catheter may include markings, such as those similar to aruler, along its length to indicate the depth to which the catheter isinserted into the patient.

2. Method of Using an Integrated Vascular Delivery System

As shown in FIGS. 5A-5F, the method 200 of an integrated vasculardelivery system preferably includes the steps of: supplying a frameforming a perimeter S210, wherein the frame is configured to receive acatheter having a distal end contained within the perimeter and includesa first hub, a second hub, and a fluidic channel; folding the frame tomodify the perimeter of the frame S220, thereby freeing the distal endof the catheter from the perimeter of the frame; inserting the catheterinto the patient at an insertion site S230; unfolding the frame torestore the perimeter of the frame around the distal end of the catheterand insertion site S240; securing the frame to the patient at aplurality of anchoring points distributed around the insertion siteS250, thereby stabilizing the catheter relative to the insertion site;and allowing fluid to flow between the catheter and the patient S260.The method 200 may be performed to obtain access to the blood vessel ofa patient, such as one undergoing intravenous (IV) therapy. The methodmay be used to administer drugs, antibiotics, saline, blood, or anysuitable fluid to a patient, and/or to remove fluid from the patient.The method may be used to create, stabilize, and maintain an IV line atan insertion site on a peripheral vein or artery such as on the arm,hand, or leg, or for central venous access on the neck, chest, orabdomen, or any suitable IV location. Furthermore, the method may beused to create, stabilize, and maintain any suitable catheter-basedaccess to a patient, such as catheters for transfer of cerebrospinalfluid.

As shown in FIG. 5A, the step of supplying a frame S210 preferablyincludes supplying an integrated vascular delivery system such as thatdescribed above. However, the integrated vascular delivery system mayalternatively be any suitable system with a frame, first hub and secondhub, and a fluidic channel in which the frame can be folded to pass thefirst hub towards the second hub. For example, a frame forming aperimeter may include a first hub and a second hub coupled with a hingedjoint. Furthermore, the integrated vascular delivery system may includefewer or more hubs.

The step of folding a frame S220 functions to expose an insertable endof the catheter and to provide visual clearance for the catheter to bepositioned at an insertion site and physical clearance to access theinsertion site. As shown in FIGS. 58 and 6A, the step of folding theframe preferably includes passing the first hub of the frame over thesecond hub of the frame in a first direction. The first hub of the frameis preferably a proximal portion of the frame relative to the patientmidline, and the second hub of the frame is preferably a distal portionof the frame relative to the patient midline, but the first hub andsecond hub may be any suitable portions of the frame. For example, asshown in FIG. 5F, relative to an insertion site at the crook of an elbowof a patient, the first hub is preferably closer to the elbow and thesecond hub is preferably closer to the hand, such that the step offolding a frame folds the first hub away from the patient, and typicallytowards a medical caregiver using the system who is standing in front ofthe patient.

The step of inserting the catheter into the patient at an insertion siteS230 includes inserting a needle into a catheter, penetrating theinsertion site with the needle, positioning the catheter within theinsertion site, and withdrawing the needle from the catheter. The stepof inserting the catheter into the patient functions to create a conduitthrough which fluid can be administered to the patient. In performingthe step of penetrating the insertion site with the needle, the needleis preferably pointed proximally relative to the midline of the patient.The step of inserting a needle into a catheter preferably includesinserting a needle through the second hub of the frame, which introducesa piercing tool that is adapted to penetrate the insertion site forcatheter insertion. The steps of penetrating the insertion site,positioning the catheter, and withdrawing the needle are known and usedby one ordinarily skilled in the art. As shown in FIG. 5C, in a firstvariation, inserting a needle through the catheter includes passing theneedle over the first hub of the frame and through the catheter S232,which maintains the folded orientation of the frame during catheterinsertion and to help hold the first hub in place to prevent the firsthub from obstructing needle access to the second hub. As shown in FIGS.6A-6C, in a second variation, inserting a needle through the catheterincludes passing the needle under the first hub of the frame and throughthe catheter S234. In this second variation, the first hub is preferablyseated in, or otherwise coupled to an additional mechanism such as aneedle housing.

The step of unfolding the frame S240 functions to restore the perimeterof the frame around the distal end of the catheter and insertion site.As shown in FIG. 50, the step of unfolding the frame preferably includespassing the first hub of the frame over the second hub of the frame in asecond direction. The second direction is preferably opposite of thefirst direction, but may alternatively be any suitable direction andrestores the perimeter of the frame around the insertion site. The stepof unfolding the frame is facilitated by the step of withdrawing theneedle from the catheter, since the needle or other mechanism to whichthe first hub is coupled is no longer present to hold the first hub inplace.

The step of securing the frame to the patient S250 at a plurality ofanchoring points around the insertion site functions to stabilize thecatheter relative to the insertion site. As shown in FIG. 5E, the stepof securing the frame to the patient includes securing the first hub ofthe frame to the patient at a first anchoring point adjacent to theinsertion site, and securing the second hub of the frame to the patientat a second anchoring point opposite the first anchoring point acrossthe insertion site. The plurality of anchoring points preferably includeat least two anchoring points approximately opposite to each other, andmore preferably include anchoring points distributed approximatelyequally around the insertion site. In particular, the first anchoringpoint is preferably distal to the insertion site and the secondanchoring point is preferably proximal to the insertion site, relativeto the patient. Securing the frame to the patient on two opposite sidesof the insertion site functions to effectively reduce or eliminatemotions of the catheter within the vein and reduce or eliminate theoccurrence of painful and patient-endangering complications includingcatheter dislodgement, infiltration, and phlebitis. In some variations,the step of securing the frame includes securing any suitable number ofhubs at one anchoring point or three or more anchoring points. The firstanchoring point is preferably proximal to the insertion site relative tothe midline of the patient, and the second anchoring point is preferablydistal to the insertion site relative to the midline of the patient, butthe first anchoring point and second anchoring point may be at anysuitable location relative to the insertion site. Each securing step mayinclude taping the frame to the patient, adhering the frame to thepatient with adhesive, strapping the frame to the patient, or anysuitable securing mechanism.

The step of allowing the fluid to flow between the catheter and thepatient S260 functions to administer fluid to the patient and/or removefluids from the patient. As shown in FIG. 5F, the step of allowing thefluid to flow preferably includes connecting the fluidic channel to afluid supply or reservoir. The fluidic channel is preferably connectedto the fluid supply or reservoir by fluidly connecting fluidic channelto extension tubing as is well known in the art, but may alternativelybe connected to the fluid supply by connecting any suitable portion ofthe frame through any suitable method. The fluid supply is preferably anIV bag, but may alternatively be any suitable fluid supply. In somevariations in which the integrated vascular delivery system includesmultiple fluidic channels, the step of allowing the fluid to flowincludes connecting a second fluidic channel to a second fluid supply orreservoir.

The method may additionally further include the step of applying adressing over the insertion site and the frame. The step of applying adressing functions to protect the insertion site against bacteria,viruses, and other pathogens. The dressing is preferably a breathable,sterile dressing such as Tegaderm, which is known and used to oneskilled in the art. As shown in FIG. 5F, the dressing is preferablytransparent to allow visualization of the insertion site, and includesadhesive to attach to the skin of the patient and to provide securementof the frame. However, the dressing can include any suitable device ormethod to assist in the protection of the insertion site.

As a person skilled in the art will recognize from the previous detaileddescription and from the figures and claims, modifications and changescan be made to the preferred embodiments of the invention withoutdeparting from the scope of this invention defined in the followingclaims.

1.-20. (canceled)
 21. An integrated vascular delivery system comprising:a first hub having a proximal region, the first hub comprising: acatheter configured for insertion into a patient extending from theproximal region; and at least one fluidic channel configured tocommunicate with the catheter within the first hub and extending fromthe proximal region of the first hub; a second hub spaced apart from thefirst hub and configured to stabilize the system; and a first and asecond lateral member extending between the first hub and the secondhub, wherein the at least one fluidic channel passes through at leastone of the first and second lateral members.
 22. The system of claim 21,wherein the lateral member including the fluidic channel extends from acentral portion of the first hub to a spaced apart portion of theproximal region.
 23. The system of claim 21, wherein the at least onefluidic channel passes through the first hub at an angle such that theat least one fluidic channel extends from a center of the first hub toan outer peripheral portion of the proximal region of the first hub. 24.The system of claim 21, wherein the at least one fluidic channelincludes a fixed turnabout portion in which a direction of fluid flowthrough the at least one fluidic channel is angularly displaced byapproximately 180 degrees.
 25. The system of claim 21, wherein the firstand second lateral members are bendable and configured to allow one ofthe first and second hubs to fold over the other of the first and secondhubs.
 26. The system of claim 21, wherein at least one of the first andsecond lateral members extends through the second hub.
 27. The system ofclaim 21, wherein the first and second lateral members extend throughthe second hub.
 28. The system of claim 21, wherein the at least onefluidic channel comprises a first fluidic channel and a second fluidicchannel.
 29. The system of claim 28, further comprising a firstextension tube defining a first flow path and a second extension tubedefining a second flow path, the first extension tube fluidicallycoupled to the first fluidic channel and the second extension tubefluidically coupled to the second fluidic channel.
 30. The system ofclaim 29, wherein the first extension tube is integrally formed with thefirst fluidic channel and extends through the second hub and the secondextension tube is integrally formed with the second fluidic channel andextends through the second hub.
 31. The system of claim 21, furthercomprising a septum coupled to the first hub, the septum beingconfigured to receive a needle.
 32. The system of claim 21, wherein thefirst hub is configured to be positioned on a first side of an insertionpoint and the second hub is configured to be positioned on a second sideof the insertion point.
 33. A method of using an integrated vasculardelivery system, the method comprising: supplying an integrated vasculardelivery system, wherein the system comprises a first hub having aproximal region, a catheter extending from the proximal region, a secondhub, a first and a second lateral member extending between the first huband the second hub, and at least one fluidic channel that fluidicallycommunicates with the catheter within the first hub, extends from theproximal region of the first hub, and passes through at least one of thefirst and second lateral members, wherein the system is configured toallow one of the first hub and the second hub to fold over the other ofthe first and second hubs, thereby exposing a proximal end of thecatheter; inserting the catheter into a patient at an insertion site;unfolding the system; and securing the system to the patient at aplurality of anchoring points around the insertion site, therebystabilizing the system relative to the insertion site.
 34. The method ofclaim 33, further comprising allowing fluid to flow between the catheterand the patient.
 35. The method of claim 33, further comprisingdecoupling at least one of the first hub and the second hub from aneedle housing.
 36. The method of claim 33, wherein the system furthercomprises a needle extending through the first hub and the catheter, themethod further comprising the step of removing the needle from the firsthub and the catheter.
 37. The method of claim 33, wherein securing thesystem comprises securing the first hub at a first anchoring pointdistal to the insertion site and securing the second hub at a secondanchoring point proximal to the insertion site.